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The FDA issued a warning letter to active pharmaceutical ingredient (API) maker Nortec Quimica of Brazil for inadequate controls over computer systems and failure to review batch production and laboratory control records prior to API distribution to the U.S. Read More
Over-the-counter (OTC) drug manufacturer Midlab of Athens, Tenn., was slapped with a six-observation FDA Form 483 for failing to validate its drug manufacturing processes and equipment and its water system, in addition to using expired raw materials. Read More
To clear up any confusion about what the FDA considers delaying, denying, limiting, or refusing a drug or device inspection, the agency released a draft guidance on Thursday. Read More
An FDA inspection of Consolidated Chemical’s St. Louis, Mo., drug manufacturing facility from July 25 to Aug. 2 resulted in a Form 483 citing water leaks, lack of water testing, poor building condition and other lapses. Read More
The FDA issued a 10-observation Form 483 to Aurobindo’s Telangana, India, plant after a November visit, outlining several violations of current good manufacturing practices (cGMP). Read More
A large part of the FDA inspection process is reviewing documents and they need to be accessible promptly on request, an FDA inspections expert advised at the recent WCG FDAnews Annual FDA Inspections Summit in Washington, D.C. Read More
Complete document archives with self-explanatory file names are the top two — out of the top 10 — ways to be prepared for an FDA inspection, advised an FDA inspections expert at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
The integrity of manufacturers’ data is a major focus of FDA inspections and the agency’s investigators will go to great lengths to uncover problems, three former FDA inspection officials told attendees at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C. last week. Read More
Aarkish Pharmaceuticals received a nine-observation Form 483 for missing records and other quality lapses observed during an inspection of its Fairfield, N.J., facility. Read More
The FDA issued a nine-observation Form 483 to ImprimisRx’s Ledgewood, N.J., facility for unsanitary conditions and other deficiencies observed during a July 11 to Aug. 5 inspection. Read More
Appco Pharma’s Piscataway, N.J. generic drug manufacturing facility was dinged by the FDA for lacking temperature and humidity records for some equipment and other documentation lapses listed in a five-observation Form 483 following an Aug. 8-19 inspection. Read More